Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810. Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.
This recall has been terminated (originally issued April 7, 2009).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- March 10, 2009
- Posted
- April 7, 2009
- Terminated
- June 26, 2009
- Recall Number
- Z-1174-2009
- Quantity
- 125 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings.
Distribution
Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.
Lot / Code Info
Lot number 105BA0105205
Root Cause
Nonconforming Material/Component
Action Taken
Urgent: Product Recall Notification letters, dated March 10, 2009, were sent out by first class mail to all consignees. The letters asked consignees to quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Consignees also need to complete and return the "Recall Acknowledgement and Return Form" indicating whether or not they possess any affected product. Additional questions should be directed to Judith O'Grady at 609-936-2311.